Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin irritation: Key study: p-Phenetidine was considered as slightly irritant by the Cosmetic and AFNOR protocols and non-irritant by OECD (skin irritation)
Eye irritation: According to the AFNOR protocol, p-phenetidine is very irritating (without rinsing) (eye irritation).

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Key study: experimental result: test according to the method published by the French authorities for the testing of cosmetics and toiletries (Journal Officiel 21 April 1973) and the methods proposed for the testing of chemicals by the Association Francaise de Normalisation (AFNOR) and, in 1979, by the Organisation for Economic Cooperation and Development.

The primary cutaneous irritation of 56 chemicals was tested in the rabbit using three different procedures. The results of the three sets of tests were compared and the effects of differences in procedure and numbers of animals were studied, together with the possible relation between irritancy and the pH of the test material. It was concluded that the AFNOR protocol best met the requirements for such tests and that gloves should be worn for the handling of all substances classified as moderately or severely irritant on that scale.

p-Phenetidine was considered as slightly irritant by the Cosmetic and AFNOR protocols and non-irritant by OECD.

Key study: experimental result: test according to the proposed by the Association Francaise de Normalisation (AFNOR) in 1982 and by the Organisation for Economic Cooperation and Development in 1979 for the testing of chemicals and that published by the French authorities (Journal Officiel 21 April 1971) for the testing of cosmetics and toiletries.

The ocular irritancy of 56 chemicals was tested in the rabbit eye, with and without rinsing, using three different procedures. The results obtained were used to establish the extent to which the assessment of a chemical's irritation potential was affected by the differences between the three protocols in respect of the observation times prescribed, the inclusion and timing of rinsing, the number of animals used and the interpretation procedure. Conclusions were also drawn about the influence of the physical state and pH of a material on its potential irritancy and about the level of irritancy that necessitates the use of eye protection.

The experience has shown that the various ocular irritation indices are not a particularly helpful guide in themselves; a graduated scale of irritancy taking into account both these indices and the reversibility of the lesions seems a preferable basis for the interpretation of results.

According to this paper, the AFNOR protocol best meets these criteria. According to the AFNOR protocol, p-phenetidine is very irritating (without rinsing).

 



Effects on eye irritation: highly irritating

Justification for classification or non-classification

The substance is included in Table 3 of Annex VI of CLP Regulation (harmonised classification and labelling) and classified as:

Eye irritation Category 2

The available information on skin and eye irritation studies supports the classification as Eye irritant Category 2 and the no classification for skin irritation.